NCT02259023

Brief Summary

Purpose: The objective of this study is to determine the effect different sources and forms of discretionary foods have on stress perception in healthy adults in a free living, real world setting. Rationale: The rationale for conducting this study is to test the effects of sugar-sweetened beverages and grain-based desserts have on perceived health and stress perception, since the evidence for this topic is limited.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

September 29, 2014

Last Update Submit

October 24, 2017

Conditions

Stress PerceptionDiscretionary CaloriesOver All Health

Keywords

Stress PerceptionDiscretionary CaloriesHealth

Outcome Measures

Primary Outcomes (1)

  • Stress Perception

    A questionnaire adapted from the SF-12 will be used to measure stress perception.

    12 weeks

Secondary Outcomes (1)

  • Body Weight

    12 weeks

Study Arms (2)

Liquid: Sugar sweetened beverage consumption

EXPERIMENTAL

Consumption of sugar-sweetened beverages

Other: Liquid: Sugar sweetened beverage consumptionOther: Solid: Grain based desserts and candy consumption

Solid: Grain based desserts and candy consumption

EXPERIMENTAL

Consumption of grain based desserts and/or candy

Other: Liquid: Sugar sweetened beverage consumptionOther: Solid: Grain based desserts and candy consumption

Interventions

Liquid: Sugar sweetened beverage consumptionOTHER

Sugar sweetened beverage consumption

Liquid: Sugar sweetened beverage consumptionSolid: Grain based desserts and candy consumption
Solid: Grain based desserts and candy consumptionOTHER

Grain based desserts and candy consumption

Liquid: Sugar sweetened beverage consumptionSolid: Grain based desserts and candy consumption

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults who consume sugar sweetened beverages and grain based desserts and candy on a regular basis
  • Free from major illnesses or chronic disease
  • Willing to consume amount of beverages and food provided to supplement usual dietary habits during each period

You may not qualify if:

  • Recently lost a significant amount or looking to lose weight
  • Recently begun a new diet or exercise regimen
  • Pregnant or nursing women
  • Report restrained eater or having less than 51% control over food preparation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota West Bank Office Building

Minneapolis, Minnesota, 55454, United States

Location

Study Officials

  • Andrew Odegaard, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 8, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

US(1)